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Type of Product	Medical Device
TGA Recall Reference	RC-2024-RN-00011-1
Product Name/Description	Surefuser+ Model Number: SFS-1002DP, SFS-1001DP, SFS-10-25PG, SFS-10-25PG, SFS-1.5-25P Lot Number: 23H09P, 23H10P, 23H17P, 23H19P, 23H21P Expiry Date: 07-2028 ARTG 92233 (Nipro Australia Pty Ltd Infusion pump, general-purpose)
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	8/01/2024
Responsible Entity	Nipro Australia Pty Ltd
Reason/Issue	Nipro received several reports of leakage occurring at the connection between infusion line tube and filter during compounding on Surefuser from a customer in Australia. Medication in the defective Surefuser leaks at the connection between the infusion line and filter (Balloon side). As a result, it may cause delay in treatment. Also, when anticancer drugs are used, the leakage may cause dermopathy. It was found out through the investigation that two specific lots of intermediate products (used for assembly infusion line tube and filter) had caused the leakage of the Surefusers.
Recall Action	Recall
Recall Action Instructions	Customers should return affected stock to their wholesaler for a credit.
Contact Information	1800 451 737 - Nipro